Generalized Anxiety DisorderCOGMANCT04421690
Computerized Cognitive Training in Middle-Aged Adults With Generalized Anxiety Disorder: A Pilot Study
A study testing Cognitive Training and Trivia Training in people with Generalized Anxiety Disorder, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
The purpose of this research is to look at the effects of computerized cognitive training on anxiety, sleep, mental abilities (cognition), and other aspects of daytime functioning, such as arousal. Read more about this study
- Who is it for?
- Ages 45 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Cognitive Training and Trivia Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 45-59 yrs of age
- no neurological or psychiatric illness, dementia, or loss of consciousness > 5 mins
- nongamers (i.e., report <1 hour of video/cognitive training games/week over last 2 yrs)
- proficient in English (reading and writing)
- computer meets technology requirements (i.e. Windows: Windows 7 or above using Internet Explorer 11 or Edge, Mozilla Firefox 41 and above, Google Chrome 48 and above; Mac OS: Mac OS X v10.8 and above using Safari 10 and above, Mozilla Firefox 42 and above, Google Chrome 48 and above; Android App: Android 6 or higher version; iOS App: iOS 10 or higher version
- meet clinical dx criteria for Generalized Anxiety Disorder.
Who cannot join
- unable to provide informed consent
- unable to undergo randomization
- Telephone Interview for Cognitive Status-modified (TICS) score <33, 2)
- other sleep disorder (i.e., sleep apnea, Periodic Limb Movement Disorder-PLMD, narcolepsy, REM Sleep Behavior Disorder)
- severe untreated psychiatric comorbidity that renders randomization unethical
- psychotropic, anxiolytic medications or other medications(e.g., beta-blockers) that alter mood or sleep
- uncorrected visual/auditory impairments
- participation in nonpharmacological treatment for sleep/fatigue/mood outside the current study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Computerized Cognitive Training in Middle-Aged Adults With Generalized Anxiety Disorder: A Pilot Study (COGMA)
The purpose of this research is to look at the effects of computerized cognitive training on anxiety, sleep, mental abilities (cognition), and other aspects of daytime functioning, such as arousal.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Cognitive Training, Trivia Training
- Keywords
- Anxiety, Middle-Aged, Sleep, Cognition, Older Adults
- Medical subject headings
- Generalized Anxiety Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TrainingBehavioural
Participants (n=15) will complete computerized cognitive training games and activities online 3 times/week for 8 weeks.
Trivia TrainingBehavioural
Participants (n=15) will receive computerized trivia questions to answer and submit 3 times/week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training | Experimental | 8 week computerized cognitive training Receives: Behavioral: Cognitive Training |
| Trivia Training | Active comparator | 8 week computerized trivia training Receives: Behavioral: Trivia Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Cognition - Computerized Cognitive Tasks
Complete computerized tasks. These tasks will measure cognitive functions (e.g., processing speed).
Measured: Up to 10 weeks
Objective Cognition - Computerized Cognitive Tasks
Complete computerized tasks. These tasks will measure cognitive functions (e.g., attention).
Measured: Up to 10 weeks
Objective Cognition - Computerized Cognitive Tasks
Complete computerized tasks. These tasks will measure cognitive functions (e.g., executive function).
Measured: Up to 10 weeks
Subjective Cognitive Self-Efficacy. -Cognitive Failures Questionnaire
A 25-item questionnaire. Participants rate from 0 (never) to 4 (very often) frequency of cognitive errors. Higher scores indicate lower cognitive self-efficacy.
Measured: Up to 10 weeks
Coronavirus Anxiety Scale
5- item questionnaire that assess anxiety related to the Coronavirus.
Measured: Up to 10 weeks
Anxiety - State-Trait Anxiety Inventory
Inventory that asks respondents to rate how true 20 self-descriptive statements (e.g., I feel calm) are on a 4-point scale (1 = not at all, 4 = very much so). Typically, respondents are asked to rate statements according to how they generally feel (trait-anxiety scale) and how they feel in the current moment (state-anxiety scale). Total scores range from 20 to 80, with higher scores indicating greater maladjustment.
Measured: Up to 10 weeks
Secondary outcomes (20)
Game-related experience- Sessions and duration played
During the intervention phase the cognitive training group will play games and will need to log the days and duration played.
Measured: Up to 10 weeks
Circadian Rhythm- Morningness-Eveningness Questionnaire
19-item questionnaire that assesses preference for morning, afternoon, and evening activities. Total score reflects degree of "morningness" or "eveningness" type.
Measured: Up to 10 weeks
Subjective Arousal- Global Cognitive Arousal-Perceived Stress Scale
Perceived Stress Scale is a self-report measure of how life situations are perceived as stressful. The scale consists of 15 items corresponding to everyday situation and participants are asked to rate on a likert scale from 0 (never) to 4 (very often) how often they felt or thought a specific way. Higher scores correspond to higher perceived stress.
Measured: Up to 10 weeks
Subjective Arousal- Pre-sleep Arousal Scale
Pre-sleep Arousal Scale is a 16-item self-report questionnaire comprising both cognitive and somatic manifestations of arousal.
Measured: Up to 10 weeks
Subjective Arousal- Arousal Predisposition Scale Subjective Arousal- Arousal Predisposition Scale Subjective Arousal- Arousal Predisposition Scale
Arousal Predisposition Scale is a 12-item inventory that has been designed to measure the degree to which an individual experiences arousal. Higher scores indicate greater predisposition to arousal.
Measured: Up to 10 weeks
Game Engagement Questionnaire
Questionnaire assessing the experience of the game.
Measured: Up to 10 weeks
Mood-Depression-Beck Depression Inventory-II
21-item inventory that asks respondents to rate on a scale of 0 (no depressive feelings) to 3 (most depressive feelings) their feelings towards various aspects of daily living/situations. Higher total scores indicate worse depressive symptoms.
Measured: Up to 10 weeks
Alcohol Use - Alcohol Use Disorder Test
10-item questionnaire that assess the frequency of alcohol use and problems associated with alcohol use over the past year.
Measured: Baseline
Physical Activity - International Physical Activity Questionnaire
7- item questionnaire assessing the different kinds of physical activities that the participant does as pat of their everyday life.
Measured: Up to 10 weeks
Personality - Big Five Inventory
10 question assessment measuring personality.
Measured: Baseline
COVID-19 related media exposure and risk questions
20- item questionnaire assessing the effects of news and social media on perception of COVID-19.
Measured: Up to 10 weeks
Subjective Intervention Efficacy- Internet Intervention Utility Questionnaire
16- item questionnaire about the use of the intervention.
Measured: Up to 10 weeks
Computer Proficiency- Computer Proficiency Questionnaire
This questionnaire asks about participants' ability to perform a number of tasks with a computer. Will be examined as a covariate.
Measured: Baseline
Subjective Behavioral Sleep- Insomnia Severity Index
Brief self-report measure of current perception of insomnia symptom severity, distress and daytime impairment. Commonly used in insomnia treatment outcome research.
Measured: Up to 10 weeks
Beck Depression Inventory-2nd Edition
21-item inventory that asks respondents to rate on a scale of 0 (no depressive feelings) to 3 (most depressive feelings) their feelings towards various aspects of daily living/situations. Higher total scores indicate worse depressive symptoms.
Measured: Up to 10 weeks
Subjective Behavioral Sleep - Electronic Daily Sleep Diaries
Online diaries completed each morning (~5 mins); diaries measure sleep onset latency, wake time after sleep onset, total sleep time, and sleep quality.
Measured: Up to 10 weeks
Subjective Behavioral Sleep - Electronic Daily Sleep Diaries
Online diaries completed each morning (~5 mins); diaries measure sleep onset latency
Measured: Up to 10 weeks
Subjective Behavioral Sleep - Electronic Daily Sleep Diaries
Online diaries completed each morning (~5 mins); diaries measure wake time after sleep onset
Measured: Up to 10 weeks
Subjective Behavioral Sleep - Electronic Daily Sleep Diaries
Online diaries completed each morning (~5 mins); diaries measure total sleep time
Measured: Up to 10 weeks
Subjective Behavioral Sleep - Electronic Daily Sleep Diaries
Online diaries completed each morning (~5 mins); diaries measure sleep quality
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start8 Jun 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to cognitive training or trivia training and will complete measures of anxiety, sleep, cognition (objective, self-efficacy), and self-reported arousal at baseline, and post-intervention
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashley Curtis, University of Missouri-Columbia
- Investigators
- Ashley Curtis, PhD, Principal investigator, University of Missouri- School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421690
- Sponsor's protocol ID
- 2021943
- Acronym
- COGMA
- Status last verified
- Mar 2023
- First submitted
- 2 Jun 2020
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Cognitive Training in Middle-Aged Adults With Generalized Anxiety Disorder: A Pilot Study (COGMA)
- ClinicalTrials.gov ID
- NCT04421690
- Acronym / sponsor ID
- COGMA / 2021943
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Anxiety, Middle-Aged, Sleep, Cognition, Older Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to look at the effects of computerized cognitive training on anxiety, sleep, mental abilities (cognition), and other aspects of daytime functioning, such as arousal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to cognitive training or trivia training and will complete measures of anxiety, sleep, cognition (objective, self-efficacy), and self-reported arousal at baseline, and post-intervention
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training | Experimental | Behavioral: Cognitive Training8 week computerized cognitive training |
| Trivia Training | Active comparator | Behavioral: Trivia Training8 week computerized trivia training |
Who may qualify
- Ages
- 45 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 45-59 yrs of age
- no neurological or psychiatric illness, dementia, or loss of consciousness > 5 mins
- nongamers (i.e., report <1 hour of video/cognitive training games/week over last 2 yrs)
- proficient in English (reading and writing)
- computer meets technology requirements (i.e. Windows: Windows 7 or above using Internet Explorer 11 or Edge, Mozilla Firefox 41 and above, Google Chrome 48 and above; Mac OS: Mac OS X v10.8 and above using Safari 10 and above, Mozilla Firefox 42 and above, Google Chrome 48 and above; Android App: Android 6 or higher version; iOS App: iOS 10 or higher version
Key exclusion criteria (8 listed)
- unable to provide informed consent
- unable to undergo randomization
- Telephone Interview for Cognitive Status-modified (TICS) score <33, 2)
- other sleep disorder (i.e., sleep apnea, Periodic Limb Movement Disorder-PLMD, narcolepsy, REM Sleep Behavior Disorder)
- severe untreated psychiatric comorbidity that renders randomization unethical
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive TrainingParticipants (n=15) will complete computerized cognitive training games and activities online 3 times/week for 8 weeks. | Behavioural | Cognitive Training |
| Trivia TrainingParticipants (n=15) will receive computerized trivia questions to answer and submit 3 times/week for 8 weeks. | Behavioural | Trivia Training |
Primary outcome
Objective Cognition - Computerized Cognitive Tasks
Time frame: Up to 10 weeks
Complete computerized tasks. These tasks will measure cognitive functions (e.g., processing speed).
Objective Cognition - Computerized Cognitive Tasks
Time frame: Up to 10 weeks
Complete computerized tasks. These tasks will measure cognitive functions (e.g., attention).
Objective Cognition - Computerized Cognitive Tasks
Time frame: Up to 10 weeks
Complete computerized tasks. These tasks will measure cognitive functions (e.g., executive function).
Subjective Cognitive Self-Efficacy. -Cognitive Failures Questionnaire
Time frame: Up to 10 weeks
A 25-item questionnaire. Participants rate from 0 (never) to 4 (very often) frequency of cognitive errors. Higher scores indicate lower cognitive self-efficacy.
Coronavirus Anxiety Scale
Time frame: Up to 10 weeks
5- item questionnaire that assess anxiety related to the Coronavirus.
Anxiety - State-Trait Anxiety Inventory
Time frame: Up to 10 weeks
Inventory that asks respondents to rate how true 20 self-descriptive statements (e.g., I feel calm) are on a 4-point scale (1 = not at all, 4 = very much so). Typically, respondents are asked to rate statements according to how they generally feel (trait-anxiety scale) and how they feel in the current moment (state-anxiety scale). Total scores range from 20 to 80, with higher scores indicating greater maladjustment.
20 secondary outcomes
Game-related experience- Sessions and duration played
Time frame: Up to 10 weeks
Circadian Rhythm- Morningness-Eveningness Questionnaire
Time frame: Up to 10 weeks
Subjective Arousal- Global Cognitive Arousal-Perceived Stress Scale
Time frame: Up to 10 weeks
Subjective Arousal- Pre-sleep Arousal Scale
Time frame: Up to 10 weeks
Subjective Arousal- Arousal Predisposition Scale Subjective Arousal- Arousal Predisposition Scale Subjective Arousal- Arousal Predisposition Scale
Time frame: Up to 10 weeks
Game Engagement Questionnaire
Time frame: Up to 10 weeks
Mood-Depression-Beck Depression Inventory-II
Time frame: Up to 10 weeks
Alcohol Use - Alcohol Use Disorder Test
Time frame: Baseline
Physical Activity - International Physical Activity Questionnaire
Time frame: Up to 10 weeks
Personality - Big Five Inventory
Time frame: Baseline
COVID-19 related media exposure and risk questions
Time frame: Up to 10 weeks
Subjective Intervention Efficacy- Internet Intervention Utility Questionnaire
Time frame: Up to 10 weeks
Computer Proficiency- Computer Proficiency Questionnaire
Time frame: Baseline
Subjective Behavioral Sleep- Insomnia Severity Index
Time frame: Up to 10 weeks
Beck Depression Inventory-2nd Edition
Time frame: Up to 10 weeks
Subjective Behavioral Sleep - Electronic Daily Sleep Diaries
Time frame: Up to 10 weeks
Subjective Behavioral Sleep - Electronic Daily Sleep Diaries
Time frame: Up to 10 weeks
Subjective Behavioral Sleep - Electronic Daily Sleep Diaries
Time frame: Up to 10 weeks
Subjective Behavioral Sleep - Electronic Daily Sleep Diaries
Time frame: Up to 10 weeks
Subjective Behavioral Sleep - Electronic Daily Sleep Diaries
Time frame: Up to 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley Curtis, PhD principal investigator
University of Missouri- School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Training and Trivia Training in people with Generalized Anxiety Disorder, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Cognition - Computerized Cognitive Tasks (time frame: Up to 10 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.